1. Field of the Invention
The present invention is a process for generating waveforms for defibrillating the human heart and the apparatus for generating waveforms, especially the electronic circuitry, including the programming and control accessories.
2. Description of the Prior Art
Defibrillating the human heart is accomplished by applying an electrical waveform to the cardiac muscle with appropriate electrodes, causing the cessation of the rapid uncoordinated contractions of the heart, and a restoration of normal beating of the heart.
The optimal voltage-versus-time waveform for this purpose is known approximately, but not precisely. There is wide agreement in the prior art that, at a minimum, it incorporates a rectangular or approximately rectangular positive-going pulse. The adjective positive-going has meaning after one has determined the point on or near the heart that best serves as voltage reference for a particular patient, a matter that varies from person to person. In the simplest case, a single such pulse is used for defibrillation. This option is termed the "monophasic" waveform.
For the sake of a concrete description, let one choose a specific waveform that falls in the ranges of accepted values. Such an example is shown in idealized form in FIG. 3. This pulse has an amplitude of +400 volts, and a duration of 7 milliseconds. The literature on this subject is extensive, with a typical example being Feeser, et al., Circulation, volume 82, number 6, page 2128, December, 1990, an article that includes an extensive bibliography.
The electrical resistance presented by the human heart muscle to the passage of defibrillation current is quite low, usually falling in the range from 40 to 100 ohms. These low values are a combined result of the large area electrodes employed and nonlinearity to the heart muscle as an electrical resistor, with resistance declining as current increases. Because of this fact, large current values are required, typically several amperes, at the typical but arbitrarily chosen amplitude of 400 V. It is a considerable challenge to generate a rectangular waveform at such a high current, especially in a battery-powered implantable defibrillator system, which must be small and light in weight. Fortunately, an approximation to the idealized waveform is able to accomplish the desired result, but with an effectiveness that is believed to be considerably lower.
A simple and extensively used approximation to the ideal waveform can be achieved by charging a capacitor to 400 volts in the present example, and connecting it directly from one electrode to the other on the heart muscle, and letting the heart serve as the load resistance that discharges the capacitor. When a resistor is used in this manner to discharge a capacitor, the result is a voltage-versus-time waveform that declines in exponential fashion from the initial capacitor voltage, +400 volts at present. The nonlinearity mentioned above distorts the exponential waveform somewhat, but not significantly. For purposes of approximating a rectangular waveform, it is necessary to interrupt the discharging process while the voltage remains at some significant fraction of its original value. This can be accomplished by simply breaking, or "opening", the circuit formed by capacitor and resistor, the latter in this case being the heart. At that instant the voltage experienced by the heart drops abruptly to zero.
Assuming for specific illustration that in the 7-ms duration of the pulse, the waveform voltage has dropped to 200 volts, or half its initial value, we see that the "characteristic time" of the discharging process, or the time it takes the voltage to decline to about 36.8% of its initial value, must exceed 7 ms in the present case. The characteristic time in seconds is determined by the product of the resistance R in ohms and the capacitance C in farads. For the assumed requirements, one must achieve a characteristic time, or "RC time constant" of 10 ms. Continuing with specific values for illustrative purposes, let one assume a cardiac resistance of 70 ohms, requiring therefore a capacitance of 143 microfarad. Relationships are illustrated in FIG. 4A for the assumed conditions. The qualitative difference between FIGS. 3 and 4A is known in the jargon of the specialty as the degree of "tilt", and a "low-tilt" waveform is preferred. The approximate waveform is unsatisfactory if the voltage at the end of the pulse interval is a small fraction of the initial voltage, a condition that would be described as a "high-tilt" waveform.
The connection and disconnection of the capacitor to the heart muscle is accomplished in the present state of the art by means of switching networks employing the power field-effect transistor (or FET), by way of example and for purposes of illustration only and not to be construed as limiting of the present invention. This is a three-terminal, solid-state device, with one terminal being a control electrode, and the other two terminals being power electrodes. Resistance between the power terminals can be either very low (the "closed" condition), or very high (the "open" condition). Thus, the FET is functionally equivalent to the familiar mechanical single-pole, single-throw switch, and is described as such for purposes of brevity and illustration. A circuit employing a single such switch can deliver the waveform illustrated in FIG. 4A. Both the waveform and the circuit that produces it, shown in FIG. 4B, are discussed in more detail later.
The first adjective states that this switch incorporates a single pivoted armature or movable lever, and the second adjective means that there is one stable position in which current is conducted. Since description of the switching network is made more transparent by choosing the mechanical-switch option, as illustrated in FIG. 4B, which schematically presents the network that delivers the result shown in FIG. 4A as later discussed in detail.
Another waveform of the prior art is the "biphasic" waveform, which is capable of achieving defibrillation with less energy than that necessary, with the monophasic waveform. This difference is of prime importance to implantable systems because the total energy deliverable by a battery over its life is approximately proportional to its size and weight.
In a biphasic waveform, a positive pulse of the kind described earlier is followed by a negative pulse. Ideally, the negative pulse should be rectangular, should be comparable in amplitude to the positive pulse, and should have a duration somewhere between 10% and 90% that of the total pulse width. Continuing with specific examples, let one adopt as the positive waveform that of FIG. 5A, where the duration of the negative pulse is shown to be 3 ms. The simplest biphasic switching network of the prior art delivers a negative pulse with a initial amplitude equal to that at the end of the positive pulse, as is illustrated in FIG. 5A. One embodiment of a network for delivering this combined waveform is illustrated in FIG. 5B. This circuit employs two single-pole, triple-throw switches. Such a switch can be realized by using three FETs that all have one power electrode in common. Since the two switches are linked in order to function in coordination, they can be described as a single double-pole, triple-throw switch. Here, c designates the charging position, p the positive-pulse position, and n the negative-pulse position.
The present invention overcomes the disadvantages of the prior art by providing switching networks that provide, for example, discharging of two capacitors in parallel during the positive pulse, and in series during the negative pulse, and that can also be discharged in sequence, if desired. Straightforward extensions of such principles provide switching networks that employ two or more capacitors, and that provide arbitrary combinations of parallel, series, and sequential discharging of the capacitors, with appropriate control-signal patterns, in order to tailor the resulting waveform into an approximation of any desired ideal waveform, within wide ranges. By similar manipulation of capacitor interconnections, it is possible to capture and use pulse portions that are simply discarded in the prior art, thereby permitting one to achieve certain waveforms with less capacitance than was required before. Because the capacitor is physically the largest component in a prior art defibrillator, reduction in its value and hence size is significant. Such a waveform is illustrated in FIG. 8C. It constitutes a better approximation to the ideal monophasic waveform of FIG. 3 than does the prior art waveform of FIG. 4A, but yet it requires 11% less capacitance than the prior art case. To accomplish control and setting of the switching network from outside the body, it is foreseen that digital programming through, for example, RF electromagnetic radiation, will be used as it now is for other systems such as pacemakers. It is further provided that a telemetry relay positioned at or on the body can be employed to facilitate the digital programming. It is further proposed that photovoltaic devices be subcutaneously implanted to charge the implanted batteries. Particularly useful here are series-array "solar" cells, with the monolithic series-array versions of the prior art being especially well-adapted. A further option, of course, is the use of an implanted coil as in the prior art that is powered by an external source of electromagnetic radiation.